Sprayable topical carrier and composition comprising phosphatidylcholine

ABSTRACT

A pharmaceutical or cosmetic carrier for topical administration substantially consists of phosphatidylcholine, monoglyceride, fatty acid ester of C 1 -C 3  alcohol; volatile solvent selected from ethanol and its combinations with C 3 -C 4  alcohol and/or volatile silicone oil. Also disclosed are pharmaceutical and cosmetic compositions comprising the carrier and pharmaceutically or cosmetically active agent(s).

FIELD OF THE INVENTION

The present invention relates to a carrier for pharmaceutically and/orcosmetically active agents and to pharmaceutical and cosmeticcompositions for topical administration comprising the carrier andpharmaceutically or cosmetically active agents.

BACKGROUND OF THE INVENTION

Pharmaceutical compositions for topical administration are of two kinds:one kind aiming at administering a pharmaceutically active agent ontohealthy or diseased skin to produce its effect on the skin and/or in oneor more layers of the skin, the other kind aiming at the delivery of apharmaceutically active agent through the skin. Cosmetic compositionsare designed for topical administration onto healthy skin and forproducing their effect on the skin.

WO 2011/056115 discloses a lipid carrier composition, comprising orsubstantially consisting of polar lipid, volatile silicone oil, and alower alcohol.

OBJECTS OF THE INVENTION

It is an object of the invention to provide a liquid pharmaceutical orcosmetic composition for topical administration of a pharmaceutically orcosmetically active agent, respectively, to the skin of a person or ananimal, which is easily administrable and capable of forming a coherentlipid layer on the skin. It is desirable that the aforementionedcomposition exhibits one or more of the following features uponapplication to the skin:

-   -   re-establishment of the protective barrier of the skin if        applied to skin if said barrier has been compromised; and/or    -   lack of skin irritation.

Other objects of the invention include providing a carrier for apharmaceutically or cosmetically active agent intended foradministration to the skin of a person or an animal and a method forincorporating the active agent into the carrier so as to form a topicalpharmaceutical or cosmetic composition. Further objects of the inventionwill be evident from the following summary of the invention, preferredembodiments thereof described in form of examples, and from the appendedclaims.

SUMMARY OF THE INVENTION

According to the present invention is disclosed a pharmaceutical orcosmetic carrier for topical administration substantially consisting ofphosphatidylcholine, monoglyceride, fatty acid ester of C₁-C₃ alcoholand volatile solvent comprising ethanol. The carrier may optionallycomprise one or more members of the group consisting of antioxidant,colorant, odorant, preservative, and denaturant.

More particularly, the pharmaceutical or cosmetic carrier of theinvention for topical administration consists substantially of:phosphatidylcholine; monoglyceride; fatty acid ester of C₁-C₃ alcohol;volatile solvent selected from the group consisting of: ethanol; ethanoland C₃-C₄ alcohol; ethanol and volatile silicone oil; ethanol, C₃-C₄alcohol and volatile silicone oil; wherein the carrier optionallycomprises one or more members of the group consisting of antioxidant,colorant, odorant, preservative, and denaturant.

Phosphatidylcholine of the invention can be natural or synthetic.Natural phosphatidylcholine includes enriched phospholipid from soybeans(soy lecithin, soy-PC, for example Lipoid S 100 and Lipoid S 75),sunflower or rapeseed, containing at least 50% by weight ofphosphatidylcholine, the remainder consisting mainly of other polarlipids (such as phosphatidylethanolamine, phosphatidylglycerol,phosphatidylinositol and galactolipids) and acylglycerols(monoacylglycerols, diacylglycerols and triacylglycerols). Examples ofsynthetic phosphatidylcholine comprise dioleoyl phosphatidylcholine anddimyristoyl phosphatidylcholine.

In this application “on the skin” includes the outermost layer of theskin, the stratum corneum. A pharmaceutical or cosmetic composition ofthe invention is designed for topical administration to the skinincluding to interstices in the stratum corneum.

According to the present disclosure, “vehicle” is synonymous with“carrier”.

Commercially available monoglycerides suitable for use in the inventioncomprises mixtures of monoacylglycerol with diglycerides(diacylglycerol) and/or triglycerides (triacylglycerol). Examples ofmonoglycerides include, but are not limited to, medium chainmonoglycerides containing 40% by weight or more of C₈-C₁₀monoacylglycerol and monoolein containing 50% by weight or more ofmonooleoylglycerol. Preferred fatty acid esters of the invention areisopropyl myristate, isopropyl palmitate, ethyl oleate and methyllaurate.

In addition to ethanol, the volatile solvent of the invention maycomprise one or more of C₃-C₄ alcohol, such as isopropanol andn-butanol, and volatile silicone oil, such as cyclomethicone 5-NF(decamethylcyclopentasiloxane) and/or, less preferreddodecamethylcyclohexasiloxane and/or decamethyltetrasiloxane. Allcomponents of the volatile solvent have a boiling point of 200° C. orless at ambient pressure (1 atm), except for volatile silicone oil,which may have a boiling point at 1 atm of up to 250° C. Preferredsilicone oils have boiling points in the range of 180-250° C. at 1 atm.

Into the pharmaceutical carrier of the invention may be incorporated oneor more pharmaceutically active agents, whereby a pharmaceuticalcomposition for topical administration is formed. The composition of theinvention is intended to efficiently deliver the active agent into theskin and is neither intended nor useful for transdermal delivery of apharmaceutically active agent. The one or more pharmaceutically activeagent of the invention is selected from the group consisting of:antimicrobial agent, antibiotic; antimycotic agent; antibacterial agent;antifungal agent; antiviral agent; antiseptic; anti-phlogistic;anti-pruritic agent; anti-psoriatic agent; antitussive agent;anti-alopecia agent; anti-acne agent; anti-inflammatory agent;analgesic; antiulcer agent; local anaesthetic; and immune responsemodifying agent.

More particularly, the pharmaceutically active agent of the invention isselected from: antibacterial agents, such as oxytetracycline, fusidicacid, gentamycine, mupirocin, retapamulin (and pharmaceuticallyacceptable salts and derivatives thereof); antimycotic agents, such asnystatin, clotrimazole, miconazole, econazole, ketoconazole, bifonazole,and combinations of imidazole and triazole derivatives, ciclopirox,terbinafine, fluconazole, and amorolfine (and pharmaceuticallyacceptable salts and derivatives thereof); antiviral agents, such asaciclovir, valaciclovir, penciclovir, famciclovir, foscarnet (trisodiumphosphonoformate hexahydrate) and docosanol (and pharmaceuticallyacceptable salts and derivatives thereof); antiseptics, such aschlorhexidine, benzalkonium chloride and hydrogen peroxide;anti-inflammatory agents (glucocorticoids), such as hydrocortisone,clobetasone, triamcinolone, betamethasone, mometasone, and clobetasol(and pharmaceutically acceptable salts and derivatives thereof);antiphlogistics/analgesics, such as acetylsalicylic acid, salicylicacid, diclofenac, ketoprofen, ibuprofen, naproxen, capsaicin, nicotinate(and pharmaceutically acceptable salts and derivatives thereof);antipruritic agents, such as glucocorticoids, for example,hydrocortisone, clobetasone, clobetasol, desonide, mometasone andbetamethasone, and local anaesthetics, for example, lidocaine andprilocaine (and pharmaceutically acceptable salts and derivativesthereof); antipsoriatic agents, such as calcipotriol, calcitriol,7-dehydrocholesterol, cholecalciferol, maxacalcitol, doxercalciferol,paricalcitol, inecalcitol, eldecalcitol, betamethasone and cyclosporineA (and pharmaceutically acceptable salts and derivatives thereof);agents for treatment of eczema and atopic dermatitis: tacrolimus andpimecrolimus (and pharmaceutically acceptable salts and derivativesthereof); antiglaucomateous agents, such as timolol, betaxolol,latanoprost, bimatoprost, and travoprost (and pharmaceuticallyacceptable salts and derivatives thereof); local anaesthetics, such aslidocaine, prilocaine, ropivacaine, mepivacaine, bupivacaine,levobupivacaine, benzocaine, and tetracaine (and pharmaceuticallyacceptable salts and derivatives thereof); agents for erectiledysfunction, such as alprostadil (prostaglandin E1) (andpharmaceutically acceptable salts and derivatives thereof);anti-dandruff agents, such as selenium sulphides, piroctone oleamine andketoconazole; anti-alopecia agents, such as minoxidil (andpharmaceutically acceptable salts and derivatives thereof); anti-acneagents, such as tretinoin (retinoic acid), isotretinoin, adapalene,benzoyl peroxide, clindamycin, azelaic acid, niacinamide (andpharmaceutically acceptable salts and derivatives thereof); woundhealing agents, such as pantothenic acid, dexpanthenol and fusidic acid(and pharmaceutically acceptable salts and derivatives thereof); steroidhormones, such as prednisone, dexamethasone, triamcinolone,fludrocortisone, testosterone, estradiol, distilbestrol; and peptidehormones, such as oxytocin, LL-37, DPK-060 and PXL-01 (andpharmaceutically acceptable salts and derivatives thereof).

According to an embodiment, the at least one pharmaceutically activeagent is calcipotriol, betamethasone (or esters thereof), hydrocortisone(or esters thereof), mometasone furoate and/or diclofenac (or saltsthereof).

An antioxidant of the invention is any additional component thatinhibits other components from degrading due to oxidation. Antioxidantsare exemplified by, but not limited to, reducing agents such as thiols,ascorbic acid, or polyphenols, free radical scavengers such astocopherols (Vitamin E) and tocotrienols, sequestering agents such asEDTA and phosphonates, or organic acids such as acetic acid, glycolicacid or lactic acid. A person skilled in the art understands whichcolorants, odorants and preservatives are suitable for a carrieraccording to the present invention.

A denaturant as defined in this disclosure is an agent or mixture ofagents making the composition of the invention unattractive for humanconsumption. Examples of denaturants are esters of phthalic acid,2-isopropyl-5-methyl-phenol, denatonium benzoate,3-methyl-cyclopentadecanone, ethyl acetate and their combinations. C₃-C₄alcohols may be a part of the denaturant system but in the context ofthe invention they are comprised by the volatile solvent describedherein. At room temperature (20° C.), a convenient temperature foradministration, the carrier and the composition of the invention aresingle-phase homogeneous liquids. They are preferably administered tothe skin by spraying. For administration any spraying pump suitable fortopical administration of liquid compositions can be used. Evaporationof the volatile solvent from the skin leaves a coherent layer thereon.The layer so formed lacks a greasy feeling, reduces water loss throughthe skin, and re-establishes the protective skin barrier if compromised.

The carrier and the compositions of the invention are well tolerated byhealthy and irritated human skin.

After evaporation of the solvent the non-volatile components of thecarrier and the compositions of the invention form a continuous, singlephase layer on the skin that reduces water loss through the skin.

A pharmaceutically active agent comprised by the composition of theinvention may be any agent suitable for treating a skin conditionamenable to topical treatment.

The composition of the invention is particularly useful for treatinginflammatory conditions, such as atopic dermatitis. Hydrocortisone is apreferred pharmaceutically active agent for treating erythema that canbe incorporated into the carrier of the invention and can be comprisedby the composition of the invention. Diclofenac is another preferredpharmaceutically active agent for treating inflammation of the skin thatcan be incorporated into the carrier of the invention and can becomprised by the composition of the invention.

The pharmaceutical composition of the invention is also particularlyuseful for treating psoriasis. Calcipotriol is a preferredpharmaceutically active agent for treating psoriasis that can beincorporated into the carrier of the invention and can be comprised bythe composition of the invention.

According to a first aspect of the invention, there is provided apharmaceutical or cosmetic carrier for topical administrationsubstantially consisting of:

phosphatidylcholine;

monoglyceride;

fatty acid ester of C₁-C₃ alcohol;

volatile solvent selected from the group consisting of:

ethanol; ethanol and C₃-C₄ alcohol; ethanol and volatile silicone oil;ethanol, C₃-C₄ alcohol and volatile silicone oil;

wherein the carrier optionally comprises one or more members of thegroup consisting of antioxidant, colorant, odorant, preservative anddenaturant.

According to an embodiment of the invention, the carrier comprises: from2% or 5% to 15% or 20% or 25% or 30% or 40% by weight ofphosphatidylcholine;

from 2% or 5% to 15% or 20% or 25% by weight of monoglyceride;

from 2% or 5% to 15% or 20% or 25% or 30% by weight of fatty acid esterof C₁-C₃ alcohol;

the remainder being ethanol at a concentration of at least 25%, theethanol optionally comprising one or several of:

-   -   i) up to 20% or 30% or 40% or even up to 50% by weight of C₃-C₄        alcohol;    -   ii) up to 50% or 60% or even 75% by weight of volatile silicone        oil;    -   iii) up to 1% by weight of antioxidant, colorant, odorant,        preservative, and denaturant.

According to an embodiment, the amount of ethanol in a carrier of theinvention is in the range of 20% to 90% by weight.

According to an embodiment, the amount of C₃-C₄ alcohol in a carrier ofthe invention is in the range of 1% to 20% by weight.

According to another embodiment, the ethanol of the carrier comprises upto 50% of isopropanol.

According to yet another embodiment, the amount of volatile silicone oilin a carrier of the invention is in the range of 10% to 55% by weight.

According to one embodiment, the carrier comprises up to 2% ofdenaturant.

Decamethylcyclopentasiloxane is a preferred volatile silicone oil of thecarrier of the invention.

The pharmaceutical composition of the invention consists substantiallyof:

a) from 90% or 95% or 98% and up to 99.999% by weight of thepharmaceutical carrier of the invention;

b) from 0.001% or 0.1% to 2% or 5% or exceptionally up to 10% by weightof at least one pharmaceutically active agent.

According to a preferred embodiment, the pharmaceutical composition ofthe invention consists of a carrier (a):

a) from 90% or 95% or 98% and up to 99.999% by weight of carrierconsisting of:

-   -   from 2% or 5% to 15% or 20% or 25% or 30% or 40% by weight of        phosphatidylcholine;    -   from 2% or 5% to 15% or 20% or 25% by weight of monoglyceride;    -   from 2% or 5% to 15% or 20% or 25% or 30% by weight of fatty        acid ester of C₁-C₃ alcohol;    -   the remainder being ethanol of a concentration of at least 25%,        the ethanol optionally comprising one or several of:    -   i) up to 20% or 30% or 40% or even up to 50% by weight of C₃-C₄        alcohol;    -   ii) up to 50% or 60% or even 75% by weight of volatile silicone        oil,    -   iii) up to 1% by weight of antioxidant, colorant, odorant,        preservative and denaturant;

and

b) from 0.001% or 0.1% to 2% or 5% or exceptionally up to 10% by weightof at least one pharmaceutically active agent; wherein the weightportions of carrier and at least one pharmaceutically active agent inthe composition are adding up to 100%.

According to one embodiment, the pharmaceutical composition comprises upto 2% denaturant.

Decamethylcyclopentasiloxane is a preferred volatile silicone oil of thepharmaceutical composition of the invention.

The cosmetic composition of the invention substantially consists of:

-   a) from 90% or 95% or 98% and up to 99.999% by weight of the    cosmetic carrier of the invention, and-   b) from 0.001% or 0.1% to 2% or 5% or exceptionally up to 10% by    weight of one or more cosmetically active agents.

The weight portions of carrier and one or more cosmetically active agentin the composition are adding up to 100%.

According to a preferred embodiment, the cosmetic composition of theinvention substantially consists of a carrier (a):

-   a) from 90% or 95% or 98% and up to 99.999% by weight of carrier    consisting of:    -   from 2% or 5% to 15% or 20% or 25% or 30% or 40% by weight of        phosphatidylcholine;    -   from 2% or 5% to 15% or 20% or 25% by weight of monoglyceride;    -   from 2% or 5% to 15% or 20% or 25% or 30% by weight of fatty        acid ester of    -   C₁-C₃ alcohol;    -   the remainder being ethanol of a concentration of at least 25%,        the ethanol optionally comprising one or several of:    -   i) up to 20% or 30% or 40% or even up to 50% by weight of C₃-C₄        alcohol;    -   ii) up to 50% or 60% or even 75% by weight of volatile silicone        oil;    -   iii) up to 1% by weight of antioxidant, colorant, odorant,        preservative, and denaturant;-   and-   b) from 0.001% or 0.1% to 2% or 5% or exceptionally up to 10% by    weight of one or more cosmetically active agent; wherein the weight    portions of carrier and at least one cosmetically active agent in    the composition are adding up to 100%.

According to an embodiment, the cosmetic composition comprises up to 2%of denaturant.

According to an embodiment, the ethanol of the pharmaceuticalcomposition comprises up to 50% of isopropanol

Decamethylcyclopentasiloxane and decamethyltetrasiloxane are preferredvolatile silicone oils of the cosmetic composition of the invention.

The cosmetically active agent of the invention may be any agent suitablefor cosmetic use capable of being incorporated into the cosmetic carrierof the invention. Preferred cosmetically active agents of the inventioncomprise: antiperspirants, such as aluminium chlorohydrate; sun screens,such as avobenzone, bemotrizinol, diethylamino hydroxybenzoyl hexylbenzoate, octisalate, octocrylene, oxybenzone; tanning agents, such asdihydroxyacetone; insects repellants, such as Deet; keratolytics, suchas glycolic acid, lactic acid, malic acid, salicylic acid, allantoin,urea and sulphur; antidandruff agents; glidants; moisturizing agents,such as glycerol, sorbitol, dexpanthenol, propylene glycol, butandiols,pentanediols, hexanediols, urea and lactic acid.

According to one embodiment, the one or more cosmetically active agentsis selected from urea, glycolic acid, lactic acid, glycerol, propyleneglycol and dexpanthenol.

The pharmacological and cosmetic compositions of the invention can beprepared by dissolving pharmaceutically active agent or cosmetic agent,respectively, in the carrier or in one or more components of the carrierfollowed by preparing the carrier by mixing its components.

According to an embodiment, a spraying device comprises a composition ofthe present invention and optionally a driving gas.

DESCRIPTION OF PREFERRED EMBODIMENTS

Material and Methods

Lipids Used in the Examples:

Short name Supplier, trade name Chemical name CAS No. S-75 Lipoid S 75Soybean phospholipid 8030-76-0 S-100 Lipoid S 100 Soybean phospholipid97281-47-5 DMPC Lipoid DMPC Dimyristoyl phosphatidylcholine 13699-48-4DOPC Lipoid DOPC Dioleoyl phosphatidylcholine 10015-85-7 H-100 Lipoid H100 Sunflower phosphatidylcholine 97281-47-5 H-50 Lipoid H 50 Sunflowerlecithin 8002-43-5 Monoolein Fluka (Sigma-Aldrich), Monooleoylglycerol25496-72-4 Monoolein MCM Abitec Corporation, Medium chainmonoglycerides, 26402-26-6 Capmul MCM C8 EP Glycerol monocaprylate IPMAldrich, Isopropyl Isopropyl myristate 110-27-0 myristate IPP Aldrich,Isopropyl Isopropyl palmitate 142-91-6 palmitate Methyl Aldrich, Methyllaurate Methyl laurate 111-82-0 laurate Ethyl Aldrich, Ethyl oleateEthyl oleate 111-62-6 oleate

Alcohols used in the examples were ethanol 99.9% (“EtOH”, VWR),2-propanol (isopropanol, HPLC grade, Rathburn), and 2-butanol(ReagentPlus®, Sigma-Aldrich). The silicone oils used in the exampleswere Cyclomethicone 5-NF (“5-NF”, Dow Corning,decamethylcyclopentasiloxane) and decamethyltetrasiloxane (“DMTS”, DowCorning).

Pharmacologically and cosmetically active agents and excipients used inthe formulation experiments (with CAS Nos) were adapalene (106685-40-9),ascorbic acid (50-81-7), benzocaine (94-36-0), betamethasonedipropionate (5593-20-4), benzyl nicotinate (94-44-0), betamethasonevalerate (2152-44-5), butylhydroxytoluene (128-37-0), calcipotriol(112965-21-6), capsaicin (404-86-4), citric acid (77-92-9), clindamycinhydrochloride (21462-39-5), curcumin (458-37-7), dexpanthenol (81-13-0),diclofenac sodium (15307-79-6), econazole nitrate (24169-02-6), glycolicacid (79-14-1), hydrocortisone (50-23-7), hydrocortisone acetate(50-03-3), ibuprofen (15687-27-1), ketoprofen (22071-15-4), lactic acid(50-21-5), methyl nicotinate (93-60-7), minoxidil (38304-91-5),mometasone furoate (83919-23-7), mupirocin (12650-69-0), naproxen(22204-53-1), oxytocin acetate (50-56-6), peptide LL-37 (humancathelicidin), propylene glycol (57-55-6), salicylic acid (69-72-7),sodium fusidate (751-94-0), tacrolimus (104987-11-3), terbinafinehydrochloride (78628-80-5), urea (57-13-6) and vitamin D₃(cholecalciferol, 67-97-0). Peptide LL-37 was from Lipopeptide AB(Solna, Sweden) and all other substances from Sigma-Aldrich.

The formulation experiments were performed according to the followinggeneral procedure. The lipids were weighed and dissolved in ethanol or amixture of ethanol and other alcohols of the invention. In someexperiments complete dissolution of the lipids was promoted by shortultrasonication in a bath-type sonicator at about 30-40° C. Pre-weighedamounts of active agent(s) and additive(s) were added to the vehicle.According to the present invention, the term “vehicle” is synonymouswith “carrier”. In some experiments the mixture was gently heated andsonicated until a clear solution was formed. The alcoholic solution oflipids was optionally diluted with volatile silicone oil. The thusobtained yellow to brownish solutions were stored in air-tight glassvials at room temperature.

The effect of prior art pharmaceutical compositions and of carriers andcompositions of the invention on human skin was observed by visualinspection or by determining erythema index by using DermaLab Combo andDSM II Colormeter (Cortex Technology, Denmark).

Measurements of methyl nicotinate induced erythema were used to studythe skin barrier function and the impact on vehicle on the delivery ofactive ingredients according to methods known in the art (Bonina F P etal., In vitro and in vivo evaluation of polyoxyethylene esters as dermalprodrugs of ketoprofen, naproxen and diclofenac. Europ J Pharm Sci 14(2001) 123-134; Duval C et al., Difference among moisturizers inaffecting skin susceptibility to hexyl nicotinate, measured as time toincrease skin blood flow. Skin Res Techn 9 (2003) 59-63; Wiren K et al.,Enhancement of bioavailability by lowering of fat content in topicalformulations. Br J Dermat 160 (2009) 552-556). An alcoholic orglycerol/water solution of methyl nicotinate (in some cases benzylnicotinate) was applied to areas on the skin either after pretreatmentwith test formulation or followed by application of the testformulation. Skin color was measured based on an active color detectingchip where illumination is provided by white LEDs and the measuredparameter (erythema index, E.I.) corresponds to the redness of the skin(Bonina F P et al., supra). Area under the curve (AUC) was calculated asthe area between the measured E.I and the baseline.

The invention is described by the following non-limiting examples.

Example 1. Occurrence of Erythema Upon Treating Skin with Carrier of theInvention Under Occlusion for 12 Days

Erythema occurrence was assessed in two human studies. In the firststudy the skin irritation potential of different lipid carriers wasevaluated. Thirty-three healthy volunteers received the testformulations and a positive and negative control under occlusiveconditions. The test articles were applied 5 days per week and theirritation grade was scored after 12 days according to a four-levelassessment index (0=No reaction; 1=Slight diffuse, partial erythema;2=Clear, sharply demarcated erythema; 3=Severe erythema with induration;4=Severe erythema with induration and/or epidermal defect). Meanassessment indices for the different treatments are presented in Table1.

For the negative control petrolatum and the two phosphatidylcholinecontaining vehicles (C and D) almost no occurrence of erythema wasobserved, whereas for the IPM (A) and MCM (B) containing vehicles aslightly higher mean assessment index was found. For the positivecontrol, sodium dodecylsulfate 0.25%, a mean assessment index of 3.0 wasobtained.

In a second study with the primary objective to evaluate the effect ofcalcipotriol compositions on plaque psoriasis, the adverse reaction oflipid carriers was also monitored. The test procedure and treatmentschedule was identical to the first study, and the number of patientswas twentyfour. After 12 days treatment erythema was not observed in anyof the patients which had received the vehicle of the invention E,whereas, in the first study, slight erythema had been observed in someof the patients treated with petrolatum and other carriers (A through D)not comprised by the invention.

TABLE 1 Erythema caused by different carriers after occlusive treatmentfor 12 days Carriers. Components in % by weight Components Pos. controlPetrolatum A B C D E* Isopropyl myristate 20 — — — 5 Medium chainmonoglycerides — 20 — — 5 Dimyristoyl phosphatidylcholine — — 20 — —Soybean lecithin, containing 50% — — — 20 10 or more ofphosphatidyl-choline Ethanol 20 20 20 20 20 Cyclomethicone 5-NF 60 60 6060 60 Sodium dodecylsulfate 0.25 Mean erythema assessment 3.0 0.03 0.310.13 0.06 0.06 0 index *Carrier of the invention.

Example 2. Nicotinate Induced Erythema Development Upon Application ofVarious Lipid Vehicles

Circular areas (3.5 cm²) were marked on the volar parts of both forearmsof healthy male persons. Baseline measurements of skin color (erythemaindex, E.I.) were made on the test areas. 5 μl of a 0.2% methylnicotinate ethanolic solution and thereafter 5 μl of the vehicles wereevenly distributed on the test areas by the use of a micropipette. E.I.was measured for about two hours. Carrier 8 of the invention decreasederythema index in respect of the carriers 7 and 9. These data indicatethat the combination of isopropyl myristate, monoglyceride andphosphatidylcholine (carrier G) is dampening erythema formation.

TABLE 2 Effect of carriers nos. F, G and H on nicotinate-inducederythema Carriers. Components in % by weight Components F G* H Isopropylmyristate 5.3 9.9 Medium chain monoglycerides 5.2 9.8Phosphatidylcholine 20.3 9.5 Ethanol 29.8 29.8 29.5 Cyclomethicone 5-NF50.0 50.5 51.0 AUC of ΔE.I. (erythema 0-2 5.2 4.6 5.1 hours) *Carrier ofthe invention

Example 3. Erythema Development after Skin Pre-Treatment withHydrocortisone Compositions

The effect of skin pre-treatment with hydrocortisone compositions onsubsequent nicotinate induced erythema was studied. Circular areas (3.5cm²) were marked on the volar parts of both forearms of healthy malepersons. 5 μl of a prior art hydrocortisone composition (ointment) and acomposition according to the invention were evenly distributed on thetest areas by the use of a micropipette. After pre-treatment with thecompositions for 2 h, baseline measurements of skin color (erythemaindex, E.I.) were made on the test areas. Erythema was induced byapplying 5 μl of a 0.4% methyl nicotinate ethanolic solution on the testareas followed by E.I. measurements over two hours. The composition ofthe invention dampened erythema development in comparison with thecommercial ointment.

TABLE 3 Effect of pretreatment with hydrocortisone compositions onerythema development AUC of ΔE.I. (erythema 0-2 Compositions. Componentsin % by weight hours) Hydrocortisone 1% ointment (CCS, Sweden)** 5.4Hydrocortisone 1% in: IPM 12.4%, MCM 13.4%, 3.4 Lipoid S 100 24.4%, EtOH49.0%* *Composition of the invention. **Prior art

Example 4. Erythema Treatment by Diclofenac Formulations Compared to theVehicles

The effect of treatment with diclofenac compositions on areas withmethyl nicotinate induced erythema was compared to the effect of thecorresponding carriers, using a procedure similar to the one describedin Example 2. All compositions reduced erythema more than their vehicles(Table 5). Composition 2 of the invention comprising aphosphatidylcholine, isopropyl myristate, and medium chain monoglycerideshowed the highest erythema reducing effect. The corresponding carrierof the invention (Carrier 2) reduced erythema more than Carriers 1 and3.

TABLE 4 Treatment of nicotinate induced erythema by diclofenaccompositions and corresponding carriers Composition or carrier.Components in % by weight Carrier # Comp. # Carrier # Comp. # Carrier #Comp. # Components 1** 1** 2* 2* 3** 3** Diclofenac sodium — 1.3 — 1.3 —1.3 Isopropyl myristate — — 5.3 4.9 9.9 10.0 Medium chain — — 5.2 4.99.8 10.0 monoglyceride Lipoid S 100 20.3 20.2 9.5 10.2 — — Ethanol 29.828.7 29.8 28.6 29.5 28.8 Cyclomethicone 50.0 49.8 50.5 50.1 51.0 50.05-NF AUC of ΔE.I. 5.2 3.8 4.6 3.5 5.1 4.2 (erythema 0-2 h) *Carrier orcomposition of the invention; **Carrier or composition not comprised bythe invention

Example 5. Erythema Treatment by Diclofenac Compositions Compared to aKnown Commercial Composition

Areas with benzyl nicotinate induced erythema were treated withdiclofenac compositions and compared to Voltaren® Gel (11.6 mg/ml),using a procedure similar to the one described in Example 2.Compositions C2 and C4 of the invention reduced erythema more thanVoltaren® Gel (Table 5).

TABLE 5 Erythema treatment by administration of diclofenac compositionsof the invention and of a state-of- the-art commercial diclofenaccomposition Compositions Components, in % by weight Voltaren ® Gel** C2*C4* Diclofenac 1.2 1.3 1.3 Isopropyl myristate — 4.9 4.9 Medium chainmonoglyceride — 4.9 4.9 Lipoid S 100 — 10.2 9.9 Ethanol — 28.6 78.9 Cyclomethicone 5-NF — 50.1 — AUC of ΔE.I. (erythema 0-2 4.6 3.2 3.8hours) *Compositions of the invention. **Prior art composition

Example 6. Erythema Treatment with Hydrocortisone and KetoprofenCompositions

Areas with methyl nicotinate induced erythema were treated with ahydrocortisone composition of the invention and a commercial ointment,using a procedure similar to the one described in Example 2. Thecomposition of the invention provided a better effect than thecommercial product (Table 6). Similarly, a ketoprofen composition of theinvention was compared with a commercial hydrophilic gel product. Theformulation of the invention provided a slightly better effect than theknown product (Table 6).

TABLE 6 Treatment of nicotinate induced erythema with hydrocortisone andketoprofen compositions AUC of ΔE.I. Compositions. Components in % byweight (erythema 0-2 h) Hydrocortisone 1% ointment (CCS, Sweden)** 4.4Hydrocortisone 1% in: IPM 12.4%, MCM 13.4%, 2.3 Lipoid S 100 24.4%, EtOH49.0%* Orudis gel (Ketoprofen 2.5%)** 3.0 Ketoprofen 1.9% in: IPM 12.1%,MCM 13.9%, 2.7 Lipoid S 100 24.5%, EtOH 47.5%* *Composition of theinvention. **Prior art composition.

Example 7. Psoriasis Plaque Test after Treatment with CalcipotriolFormulations

In a clinical study a calcipotriol composition of the invention (C6) wascompared to a commercial calcipotriol solution (Daivonex®) and to acorresponding composition lacking phosphatidylcholine. The compositionof the invention C6 resulted in the highest plaque reduction (Table 7).

TABLE 7 Change in mean plaque thickness after 12 days treatment with acommercial calcipotriol composition (Daivonex ® solution) andcalcipotriol formulations C5 and C6 Daivonex ® solution** C5** C6*Component Component % by weight Calcipotriol 0.005 0.005 0.005 Isopropylmyristate — 10.0 5.0 Medium chain monoglycerides — 10.0 5.0 Lipoid S 75— — 10.0 Ethanol — 20.0 20.0 Cyclomethicone 5-NF — 60.0 60.0 Mean changein plaque thickness −161 −179 −185 after 12 days treatment (μm)*Composition of the invention. **Prior art composition or compositionnot comprised by the invention

Example 8. Examples of Carriers and Compositions of the Invention

Examples of carriers of the invention are shown in Table 8.

TABLE 8 Carriers of the invention based on Lipoid S 100 IPM MCM Lipoid S100 Ethanol Cyclomethicone 5-NF Carrier Components % by weight a 5 10 1570 b 10 5 15 70 c 5 5 10 80 d 12.5 12.5 25 50 e 10 10 20 30 30 f 5 5 1030 50 g 5 5 10 20 60

Examples of pharmaceutical compositions of the invention are shown inTables 9-17 and examples of carriers in Table 18.

TABLE 9 Pharmaceutical compositions of the invention based on Lipoid S75 Cyclo- Lipoid methicone Active agent Agent S 75 IPM MCM Ethanol 5-NFWater Components, % by weight Benzocaine 5.10 9.9 5.2 5.1 19.9 54.8Minoxidil 0.45 10.2 5.1 5.2 19.9 59.3 Hydrocortisone 0.13 10.7 5.3 5.819.6 58.5 acetate Capsaicin 1.01 9.9 4.9 4.8 20.1 59.2 Mupirocin 0.2210.3 5.1 5.2 19.6 59.5 Betamethasone 0.09 10.7 4.8 5.1 20.1 59.3valerate Betamethasone 0.10 8.1 3.0 5.2 83.6 dipropionate TerbinafineHCl 0.98 10.4 4.5 5.3 20.0 58.9 Econazole nitrate 0.98 9.8 4.8 7.0 19.757.7 Vitamin D₃ 0.012 10.3 5.5 5.3 19.9 59.0 Salicylic acid 1.04 10.85.0 4.9 19.8 58.5 Peptide LL-37 0.22 10.1 5.0 5.2 19.9 58.8 0.8 Oxytocinacetate 0.019 9.9 4.9 7.2 19.0 57.8 1.2

TABLE 10 Pharmaceutical compositions of the invention based on Lipoid S100 Cyclo- Agent Lipoid methicone Active agent (% w/w) S 100 IPM MCMEthanol 5-NF Components, % by weight Diclofenac sodium 1.45 15.1  7.6 8.3 17.5 50.0 Diclofenac sodium 1.40  7.4  4.1  4.2 58.9 24.0Diclofenac sodium 1.33  9.9  4.9  4.9 78.9 Hydrocortisone 0.99 24.2 12.413.4 49.0 Hydrocortisone 0.32  9.3  4.3  5.7 20.3 60.2 Hydrocortisone0.10  9.0  4.9  5.4 20.3 60.3 acetate Ibuprofen 4.88 25.3 12.3 12.4 45.2Ketoprofen 0.98 10.7  5.0  4.9 78.4 Ketoprofen 1.90 24.5 12.2 13.9 47.5Ketoprofen 2.41  9.8  5.0  5.0 19.0 58.8 Ketoprofen 2.60 25.5 12.4 12.447.1 Naproxen 2.05 10.7  4.9  4.9 20.0 57.4 Naproxen 2.04 25.2 12.5 12.647.6 Sodium fusidate 2.14  3.4  9.6  9.6 19.2 56.1 Sodium fusidate 2.19 9.7  5.4  5.4 77.3 Clindamycin HCl 1.36 25.1 12.1 12.3 49.2 ClindamycinHCl 1.06 14.8  7.1  7.2 29.0 40.7

TABLE 11 Pharmaceutical compositions (% w/w) of the invention comprisingtacrolimus KL44a-2 KL44a-4 KL44a-5 KL44b-2 KL44b-4 KL44b-5 Tacrolimus1.0 1.0 1.0 1.0 1.0 1.0 Citric acid 0.6 0.3 0.2 0.3 Lipoid S 100 10.010.1 15.2 10.1 9.9 15.2 Isopropyl myristate 5.0 5.0 2.5 5.0 4.9 2.5 MCM5.0 5.0 2.5 5.0 4.9 2.5 Ethanol 78.5 79.0 78.8 78.6 79.0 78.6

TABLE 12 Pharmaceutical compositions (% w/w) of the invention comprisingcurcumin or terbinafine hydrochloride KL47f-1 KL47f-2 KL47f-3 KL47f-4KL48f-1 KL48f-2 KL48f-3 Curcumin Terbinafine HCl Active 0.30 0.30 0.300.30 1.0 1.1 1.0 Lactic acid 1.5 1.7 Urea 3.3 3.2 5.0 5.3 4.2 Lipoid S100 9.5 9.5 9.5 9.5 10.0 10.4 10.4 Isopropyl 4.7 4.7 4.7 4.7 4.9 2.8 2.5myristate MCM 4.7 4.8 4.7 4.7 4.9 2.5 3.3 Ethanol 80.7 79.2 77.5 75.974.2 77.9 78.5

TABLE 13 Pharmaceutical compositions (% w/w) of the invention comprisingbenzocaine, mupirocin, hydrocortisone acetate or vitamin D₃ KL48a-6KL48a-2 KL48a-4 Hydrocortisone KL48a-8 Benzocaine Mupirocin acetateVitamin D₃ Active 5.0 0.21 0.10 0.010 Lipoid S 100 14.2 14.9 14.9 14.2Isopropyl 7.1 7.4 7.4 7.1 myristate MCM 7.1 7.5 7.5 7.2 Ascorbic acid0.27 0.29 0.29 0.28 Ethanol 66.3 69.7 69.7 71.2

TABLE 14 Pharmaceutical compositions (% w/w) of the invention comprisingmometasone furoate KL48c-1 KL48c-2 KL48c-3 KL48c-4 KL48c-5 KL44c-2KL44c-4 KL44c-5 Mometasone 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10furoate Lipoid S 100 8.9 9.0 8.9 9.2 9.0 9.93 10.01 14.78 Isopropyl 4.64.5 4.6 4.6 4.6 4.93 4.97 2.45 myristate MCM 4.4 4.5 4.5 4.6 4.5 4.954.99 2.46 Propylene 5.2 4.6 5.2 4.6 4.9 glycol Acetic acid 0.44 0.520.23 0.49 0.24 Ascorbic acid 0.34 0.29 0.19 Butyl 0.030 0.016hydroxytoluene Isopropanol 76.4 76.9 38.4 Ethanol 76.4 76.4 38.2 79.6179.90 79.95

TABLE 15 Pharmaceutical compositions (% w/w) of the invention comprisingcalcipotriol and mometasone furoate KL48d-1 KL48d-2 KL48d-3 KL48d-4KL48d-5 Calcipotriol 0.005 0.005 0.005 0.005 0.005 Mometasone 0.10 0.100.09 0.10 0.10 furoate Lipoid S 100 5.9 19.8 6.0 Lipoid H 14.9 10.0 5.9100 Lipoid H 50 4.1 7.8 3.0 Isopropyl 4.9 5.0 2.4 myristate MCM 4.9 5.02.4 Ethanol 80.1 80.1 77.2 80.0 80.1 5-NF

TABLE 16 Pharmaceutical compositions (% w/w) of the invention comprisingdexpanthenol KL48e-1 KL48e-2 KL48e-3 KL48e-4 KL48e-5 Dexpanthenol 5.04.8 4.9 4.8 4.8 Lipoid S 100 9.9 10.0 5.2 Lipoid H 100 10.0 9.9 4.7Ethanol 44.8 45.1 75.1 75.5 60.6 Isopropyl 5.0 5.1 5.0 4.9 4.9 myristateMCM 5.0 5.1 5.0 4.9 4.9 5-NF 30.5 29.9 14.9

TABLE 17 Pharmaceutical compositions (% w/w) of the invention comprisingadapalene or clindamycin hydrochloride KL49f-1 KL49f-2 KL49f-5 KL44e-9Adapalene Clindamycin HCI Active 0.098 0.100 0.101 1.0 Lipoid S 100 19.810.2 10.1 Lipoid H 100 19.7 10.1 Isopropyl 5.0 5.4 2.5 4.6 myristate MCM5.0 5.4 2.5 5.4 Ethanol 70.2 69.3 74.6 29.0 DMTS 49.9

TABLE 18 Carriers of the invention based on various combinations oflipids and alcohols. Carrier #. Components, % by weight Component I IIIII IV V VI VII VIII Lipoid S 100 10 20 20 10 10 Lipoid S 75 20Dimyristoyl phosphatidylcholine 20 10 Dioleoyl phosphatidylcholine 10Methyl laurate 20 20 Ethyl oleate 20 20 Isopropyl myristate  5  5  5Isopropyl palmitate 10  5  5 MCM 10 10 10 20 20  5 Monoolein 10 10Ethanol 30 30 60 60 20 25 25 80 Isopropanol 40 25 25 2-Butanol 20 20

Examples nos. i) through xi) of cosmetic compositions of the inventionare shown in Table 19.

TABLE 19 Cosmetic compositions of the invention Compo- Components, % byweight sition Cosmetically Lipoid Lipoid 2- # active agent S 75 S 100IPM MCM Ethanol Propanol Butanol i Urea 4.0 30 10 10 46 ii Urea 4.0 3010 10 46 iii Urea 5.0 30 10 10 35 10 iv Lactic acid 6.0 25 15 15 39 vSodium 1.0 30 10 10 49 lactate vi Glycolic acid 5.0 30 10 10 45 viiSalicylic acid 2.0 30 10 10 38 10 viii Urea 4.8 10 5 5 73.2 Glycolicacid 2.0 ix Urea 5.0 10 5 5 74.9 x Urea 5.1 14.9 2.5 2.5 73.8 Glycolicacid 1.0 xi Salicylic acid 0.5 9.9 5.0 5.0 79.6

Example 9. Nicotinate Induced Erythema Development after Application ofCarriers of the Invention and Comparative Carriers

Circular areas (3.5 cm²) were marked on the volar parts of both forearmsof healthy male persons. Baseline measurements of skin color (erythemaindex, E.I.) were made on the test areas. 18 mm filter papers weresoaked with 160 μl of a 0.20% solution of methyl nicotinate in awater/glycerol mixture (4:1). The filter papers were placed in 18 mmFinn Chamber polypropylene coated chambers and attached to the testareas for 5 minutes. After 20 minutes, 10 μl each of carrier VIII of theinvention from Table 18 and the comparative carriers listed in Table 20were evenly distributed on the test areas by the use of a micropipette.E.I. was monitored for about two hours. The average area under the curve(AUC) for ΔE.I. was calculated for comparative carriers I, J, K, L, Mand N and for the carrier of the invention VIII. The results arepresented in Table 20. Carrier VIII of the invention gave a lowererythema reaction compared to all of the comparative carriers.

TABLE 20 Effect of carriers of the invention and comparative carriers onnicotinate induced erythema. Carriers. Components in % by weightComponents I** J** K** L** M** N** VIII* Isopropylmyristate 10 — 5 — 5 —5 Medium chain — 10 5 — — 5 5 monoglycerides Lipoid S 100 — — 10 10 1010 Ethanol 90 90 90 90 85 85 80 ΔE.I, AUC 0-2 hours 4.6 3.8 4.2 4.8 4.53.9 3.4 *Carrier of the invention; **Carrier not comprised by theinvention

The invention claimed is:
 1. Pharmaceutical or cosmetic carrier fortopical administration, said carrier comprising from 2%-40% by weight ofphosphatidylcholine; from 2%-25% by weight of monoglyceride; from 2% to30% by weight of fatty acid ester of C₁-C₃ alcohol; and volatile solventselected from the group consisting of: ethanol; ethanol and C₃-C₄alcohol; ethanol and volatile silicone oil; and ethanol, C₃-C₄ alcoholand volatile silicone oil.
 2. The carrier of claim 1, wherein the amountof volatile solvent is in the range of 20% to 90% by weight.
 3. Thecarrier according to claim 1, wherein the amount of C₃-C₄ alcohol is inthe range of 1% to 20% by weight.
 4. The carrier according to claim 1,wherein the amount of volatile silicone oil is in the range of 10% to55% by weight.
 5. The carrier according to claim 1, wherein the volatilesilicone oil is decamethylcyclopentasiloxane.
 6. Pharmaceuticalcomposition comprising: a) from 90% or 95% or 98% and up to 99.999% byweight of the carrier according to claim 1; and b) from 0.001% or 0.1%to 2% or 5% or exceptionally up to 10% by weight of at least onepharmaceutically active agent.
 7. The composition of claim 6, whereinthe at least one pharmaceutically active agent is selected from thegroup consisting of: antibacterial agents, antiviral agents,anti-inflammatory agents antiphlogistics/analgesics, antipruriticagents, local anaesthetics, antipsoriatic agents, agents for treatmentof eczema and atopic dermatitis antiglaucomateous agents, agents forerectile dysfunction, anti-dandruff agents, anti-acne agents, woundhealing agents, steroid hormones, and peptide hormones.
 8. Thecomposition of claim 6, wherein the at least one pharmaceutically activeagent is selected from the group consisting of: calcipotriol,betamethasone or esters thereof, hydrocortisone or esters thereof,mometasone furoate and/or diclofenac or salts thereof.
 9. Cosmeticcomposition comprising a) from 90% or 95% or 98% and up to 99.999% byweight of the carrier according to claim 1; and b) from 0.001% or 0.1%to 2% or 5% or exceptionally up to 10% by weight of one or morecosmetically active agents.
 10. Cosmetic composition comprising: a) from90% or 95% or 98% and up to 99.999% by weight of a carrier consistingof: from 2% or 5% to 15% or 20% or 25% or 30% or 40% by weight ofphosphatidylcholine; from 2% or 5% to 15% or 20% or 25% by weight ofmonoglyceride; from 2% or 5% to 15% or 20% or 25% or 30% by weight offatty acid ester of C₁-C₃ alcohol; the remainder being volatile solvent,wherein the volatile solvent comprises ethanol of a concentration of atleast 25% by weight, the volatile solvent optionally comprising one orseveral of: i) up to 20% or 30% or 40% or even up to 50% by weight ofC₃-C₄ alcohol; ii) up to 50% or 60% or even 75% by weight of volatilesilicone oil; iii) up to 1% by weight of antioxidant, colorant, odorant,preservative, and denaturant; and b) from 0.001% or 0.1% to 2% or 5% orexceptionally up to 10% by weight of at least one cosmetically activeagent; wherein the weight portions of the carrier and the at least onecosmetically active agent in the composition add up to 100%.
 11. Thecomposition of claim 9, wherein the one or more cosmetically activeagent is selected from the group consisting of: antiperspirants, sunscreens, tanning agents, insects repellants, keratolytics, antidandruffagents, glidants, and moisturizing agents.
 12. The composition of claim9, wherein the one or more cosmetically active agent is selected fromthe group consisting of urea, glycolic acid, lactic acid, glycerol,propylene glycol and dexpanthenol.
 13. Spraying device comprising thecomposition of claim
 6. 14. The composition of claim 7, wherein theantibacterial agents are selected from the group consisting ofoxytetracycline, fusidic acid, gentamycine, mupirocin, retapamulin, andpharmaceutically acceptable salts and derivatives thereof; theantimycotic agents are selected from the group consisting of asnystatin, clotrimazole, miconazole, econazole, ketoconazole, bifonazole,and combinations of imidazole and triazole derivatives, ciclopirox,terbinafine, fluconazole, and amorolfine, and pharmaceuticallyacceptable salts and derivatives thereof; the antiviral agents areselected from the group consisting of aciclovir, valaciclovir,penciclovir, famciclovir, foscarnet and docosanol, and pharmaceuticallyacceptable salts and derivatives thereof; the antiseptics are selectedfrom the group consisting of chlorhexidine, benzalkonium chloride andhydrogen peroxide; the anti-inflammatory agents are glucocorticoidsselected from the group consisting of hydrocortisone, clobetasone,triamcinolone, betamethasone, mometasone, and clobetasol, andpharmaceutically acceptable salts and derivatives thereof; theantiphlogistics/analgesics are selected from the group consisting ofacetylsalicylic acid, salicylic acid, diclofenac, ketoprofen, ibuprofen,naproxen, capsaicin, nicotinate, and pharmaceutically acceptable saltsand derivatives thereof; the antipruritic agents are glucocorticoidsselected from the group consisting of hydrocortisone, clobetasone,clobetasol, desonide, mometasone, and betamethasone; the antipsoriaticagents are selected from the group consisting of calcipotriol,calcitriol, 7-dehydrocholesterol, cholecalciferol, maxacalcitol,doxercalciferol, paricalcitol, inecalcitol, eldecalcitol, betamethasone,and cyclosporine A, and pharmaceutically acceptable salts andderivatives thereof; the agents for treatment of eczema and atopicdermatitis are selected from the group consisting of tacrolimus andpimecrolimus, and pharmaceutically acceptable salts and derivativesthereof; the antiglaucomateous agents are selected from the groupconsisting of timolol, betaxolol, latanoprost, bimatoprost, andtravoprost, and pharmaceutically acceptable salts and derivativesthereof; the local anaesthetics are selected from the group consistingof lidocaine, prilocaine, ropivacaine, mepivacaine, bupivacaine,levobupivacaine, benzocaine, and tetracaine, and pharmaceuticallyacceptable salts and derivatives thereof; the agents for erectiledysfunction are selected from the group consisting of alprostadil(prostaglandin E1) and pharmaceutically acceptable salts and derivativesthereof; the anti-dandruff agents are selected from the group consistingof selenium sulphides, piroctone oleamine and ketoconazole; theanti-alopecia agents are selected from the group consisting of minoxidiland pharmaceutically acceptable salts and derivatives thereof; theanti-acne agents are selected from the group consisting of tretinoin(retinoic acid), isotretinoin, adapalene, benzoyl peroxide, clindamycin,azelaic acid, and niacinamide, and pharmaceutically acceptable salts andderivatives thereof; the wound healing agents are selected from thegroup consisting of pantothenic acid, dexpanthenol, and fusidic acid,and pharmaceutically acceptable salts and derivatives thereof; thesteroid hormones are selected from the group consisting of prednisone,dexamethasone, triamcinolone, fludrocortisone, testosterone, estradiol,and distilbestrol; and the peptide hormones are selected from the groupconsisting of oxytocin and the part LL-37 of the human cathelicidinpeptide, and pharmaceutically acceptable salts and derivatives thereof.15. The composition of claim 11, wherein the antiperspirant is aluminiumchlorohydrate; the sun screens is selected from the group consisting ofavobenzone, bemotrizinol, diethylamino hydroxybenzoyl hexyl benzoate,octisalate, octocrylene, and oxybenzone; the tanning agents isdihydroxyacetone; the insects repellants isN,N-diethyl-3-methylbenzamide; the keratolytics are selected from thegroup consisting of glycolic acid, lactic acid, malic acid, salicylicacid, allantoin, urea and sulphur; and the moisturizing agent isselected from the group consisting of glycerol, sorbitol, dexpanthenol,propylene glycol, butandiols, pentanediols, hexanediols, urea, andlactic acid.